Evaluation of the effect of medlar fruit molasses (Mespilus germanica L.) on blood glucose control in children and adolescents with type 1 diabetes - A randomized clinical trial
Due to the traditional use of Medlar fruit molasses as hypoglycemic agent, the aim of this study is to evaluate the effectiveness of medlar molasses in controlling blood sugar in patients with type 1 diabetes.
Design
This study was designed as a crossover randomized clinical trial using the intention to treat approach in consecutive diabetic children referred to the diabetes clinic of Bu-Ali sina Hospital. Patients who met the inclusion criteria were randomly divided into two groups : A (medlar molasses + insulin) and B (insulin) by using a computer program to generate random numbers.
Settings and conduct
Crossover randomized clinical trial in diabetic children referred to the diabetes clinic of Bu-Ali Sina Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The age group of patients is between 5-18 years.
Children and adolescents with poorly controlled type 1 diabetes (HbA1c≥8).
The consent of the patient and parents to participate in the study has been obtained.
Exclusion criteria:
Patients with syndromic disorders (such as Down syndrome, etc.)
Presence of renal failure in the patient (GFR <30)
Taking drugs that affect blood sugar levels (lowering blood sugar such as metformin and raising blood sugar such as corticosteroids)
Intervention groups
After randomization, in the first 45 days, group A receives a certain amount of medlar fruit molasses (the dose is determined based on the total phenol content of the product) along with the required dose of insulin, and group B, only with insulin treatment. In the second 45-day period, the two groups will be swapped
Main outcome variables
C-Peptide, HbA1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160913029802N3
Registration date:2021-12-07, 1400/09/16
Registration timing:registered_while_recruiting
Last update:2021-12-07, 1400/09/16
Update count:0
Registration date
2021-12-07, 1400/09/16
Registrant information
Name
Somayeh Shahani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3761
Email address
s.shahani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of medlar fruit molasses (Mespilus germanica L.) on blood glucose control in children and adolescents with type 1 diabetes - A randomized clinical trial
Public title
Evaluation of the effect of medlar fruit molasses on blood glucose control in children and adolescents with type 1 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age group of patients is between 5-18 years.
Children and adolescents with poorly controlled type 1 diabetes (HbA1c≥8).
The consent of the patient and parents to participate in the study has been obtained.
Exclusion criteria:
Patients with syndromic disorders (such as Down syndrome, etc.)
Presence of renal failure in the patient (GFR <30)
Taking drugs that affect blood sugar levels (lowering blood sugar such as metformin and raising blood sugar such as corticosteroids)
Age
From 5 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the restricted randomization method (the blocked randomization) using Random Allocation Software. The size of all blocks is equal and in this trial, we will have five blocks of 6 (including 3 participants in group A and 3 participants in group B). Each patient will receive a unique code and the software will randomly place the patients in groups A or B, depending on the sample size in each block.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Moallem Square
City
Sari
Province
Mazandaran
Postal code
33971- 48157
Approval date
2021-09-29, 1400/07/07
Ethics committee reference number
IR.MAZUMS.REC.1400.477
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
C-Peptide
Timepoint
To determine the level of C-Peptide in patients, a blood sample is taken from the patient on an empty stomach and at intervals of 30, 60, 90 and 120 minutes after consuming a mixture of liquid (containing 50% carbohydrates, 30% fat and 20% protein with a standard concentration of 6 ml per kg, up to 360 ml).
Method of measurement
ELIZA Reader
2
Description
HbA1c
Timepoint
HbA1c (using Biroex kit) is measured at the beginning of the study, day 45 (group switching time) and the end of the study, in the laboratory of Bu-Ali Sina Hospital in Sari.
Method of measurement
Hemoglobin A1c analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: After randomization allocation, in the first 45 days, group A receives a certain amount of medlar fruit molasses (the dose is determined based on the total phenol content of the product) along with the required dose of insulin. The wash out period is two weeks, during which patients do not receive any intervention other than insulin injection.During the second 45-day period, this group will receive only the insulin they need.Patient demographic information including age, sex, height and weight as well as HbA1c levels are measured at the beginning of the study, day 45 (time of group switching) and the end of the study.
Category
Treatment - Drugs
2
Description
Intervention group B: After randomization allocation, in the first 45 days, this group will receive only the insulin they need. Then the wash out period is two weeks and during this period patients do not receive any intervention except insulin injection. In the second 45-day period, group B receives a certain amount of medlar fruit molasses(the dose is determined based on the total phenol content of the product) along with the required dose of insulin. Patient demographic information including age, sex, height and weight as well as HbA1c levels are measured at the beginning of the study, day 45 (time of group switching) and the end of the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Sina Hospital
Full name of responsible person
Dr Daniel Zamanfar
Street address
Bu-Ali Sina Hospital , Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۸۳۸۴۷۷
Phone
+98 11 3334 5601
Email
dzamanfar@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Research and Technology Deputy, Moallem square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
msaeedi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research and technology, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Somayeh Shahani
Position
Assistant Professor, Department of Pharmacognosy and Biotechnology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Mazandaran University of Medical Sciences, Km 18 of Khazarabad Road
City
Sari
Province
Mazandaran
Postal code
48471-93698
Phone
+98 11 3354 3761
Email
so.shahani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Somayeh Shahani
Position
Assistant Professor, Department of Pharmacognosy and Biotechnology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Mazandaran University of Medical Sciences, Km 18 of Khazarabad Road
City
Sari
Province
Mazandaran
Postal code
48471-93698
Phone
+98 11 3354 3761
Fax
Email
so.shahani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Somayeh Shahani
Position
Assistant Professor, Department of Pharmacognosy and Biotechnology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Mazandaran University of Medical Sciences, Km 18 of Khazarabad Road
City
Sari
Province
Mazandaran
Postal code
48471-93698
Phone
+98 11 3354 3761
Fax
Email
so.shahani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available